41da6725-a19e-4343-b2e1-2fbf27e8167f

SPL v3
SPL
SPL Set ID 41da6725-a19e-4343-b2e1-2fbf27e8167f
Route
topical
Published
Effective Date 2012-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (1 mL)
Inactive Ingredients
eucalyptus oil lemon oil orange oil peppermint oil rosemary oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-02-01
Description

camphor 3.1%

Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

camphor 3.1%

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician


Description

camphor 3.1%

Section 44425-7

store in a cool, dry place

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7

When using this product

  • avoid contact with eyes

Section 50570-1

Do not

  • apply to wounds or damaged skin
  • bandage tightly

Section 51727-6

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

Section 51945-4

Section 53413-1

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.



Section 55105-1

Topical Analgesic

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

camphor 3.1%

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises and sprains.

Dosage and Administration (34068-7)

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, massaging area gently
  • wash hands after application
  • after applying, wait 10 minutes and then wash area if desired to remove scent.  This will not decrease effectiveness.
  • children under 2 years of age: consult a physician


Section 44425-7 (44425-7)

store in a cool, dry place

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes

Section 50570-1 (50570-1)

Do not

  • apply to wounds or damaged skin
  • bandage tightly

Section 51727-6 (51727-6)

Aloe Vera Oil, Eucalyptus Globulus Leaf Oil, Lemon Peel Oil (Citrus Medica Limonum), Orange Oil (Citrus Aurantium Dulcis), Peppermint Oil (Mentha Piperita), Rosemary Leaf Oil (Rosmarinus Officinalis)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1.877.310.4173 9:00am-5:00pm EST M-F

allnaturalpainmanagement.com

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.



Section 55105-1 (55105-1)

Topical Analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:24.484022 · Updated: 2026-03-14T22:52:58.895821